Medical fluid delivery device programming

ABSTRACT

In some aspects, systems, devices, and techniques for programming a medical fluid delivery device are described. In one example, the disclosure relates to a system including a medical fluid delivery device configured to deliver a therapeutic agent to a patient, and a processor. The processor may be configured to receive a proposed therapy dosing program that defines a fluid therapy for delivery to a patient via a medical fluid delivery device for a first period of time, determine a total dosage over a second period of time, where the second period of time at least partially overlaps the first period of time, and compare the total dosage over the second period of time to a reference dosage.

This is a continuation of U.S. patent application Ser. No. 13/358,140,filed Jan. 25, 2012, which claims the benefit of U.S. ProvisionalApplication Ser. No. 61/441,460, filed Feb. 10, 2011. Each of theseapplications is incorporated herein by reference in its entirety.

TECHNICAL FIELD

This disclosure relates to programming of medical devices and, inparticular, programming of medical fluid delivery devices.

BACKGROUND

A variety of medical devices are used for chronic, i.e., long-term,delivery of therapy to patients suffering from a variety of conditions,such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary orfecal incontinence, sexual dysfunction, obesity, spasticity, orgastroparesis. Pumps or other medical fluid delivery devices may be usedfor chronic delivery of therapeutic agents, such as drugs. Typically,such fluid delivery devices provide therapy continuously or periodicallyaccording to parameters contained within a program. A program maycomprise respective values for each of a plurality of parameters,specified by a clinician. The fluid delivery devices may be implantablemedical devices that receive the program from a programmer controlled bythe clinician.

Implantable fluid delivery devices are intended to provide a patientwith a therapeutic output to alleviate or assist with a variety ofconditions. Typically, such devices provide a therapeutic output underspecified conditions on a recurring basis. One type of implantable fluiddelivery device is a drug infusion device which can deliver a fluidmedication to a patient at a selected site. A drug infusion device maybe implanted at a location in the body of a patient and deliver a fluidmedication through one or more catheters to a selected delivery site inthe body. Drug infusion devices, such as implantable drug pumps, includefluid reservoirs that may be self-sealing and may be accessible throughports. A drug infusion device may be configured to deliver a therapeuticagent from the fluid reservoir to a patient according to a therapyprogram, which may, for example, specify a rate of delivery by the IMDof a fluid delivered to the patient.

SUMMARY

In general, the disclosure relates to techniques for programming therapydelivered to a patient via a medical fluid delivery device. The therapydelivered to the patient may be delivered by the medical fluid deliverydevice according to one or more therapy dosing programs defined by aclinician or other authorized user. Prior to being used to definetherapy actually delivered to a patient via the medical fluid deliverydevice, one or more processors, e.g., a processor of an externalprogramming device, may evaluate a proposed therapy dosing program thatdefines the delivery of therapy to a patient over a first overallduration of time. In particular, the processor may compare the totaldosage of a medical fluid proposed for delivery to a patient during awindow of time (or “analysis window”) that includes a portion of thelarger, first overall duration of time of the therapy program to areference dosage. In some examples, the reference dosage used for thecomparison may be defined to correspond to the duration of the analysiswindow, e.g., a dosage range that may the suitable for delivery to thepatient based on the duration of the analysis window.

In one example, the disclosure relates to a method comprising receivinga proposed therapy dosing program that defines a fluid therapy fordelivery to a patient via a medical fluid delivery device for a firstperiod of time; determining a total dosage over a second period of time,wherein the second period of time at least partially overlaps the firstperiod of time; and comparing the total dosage over the second period oftime to a reference dosage.

In another example, the disclosure relates to a system comprising amedical fluid delivery device configured to deliver a therapeutic agentto a patient, and a processor configured to receive a proposed therapydosing program that defines a fluid therapy for delivery to a patientvia a medical fluid delivery device for a first period of time,determine a total dosage over a second period of time, wherein thesecond period of time at least partially overlaps the first period oftime, and compare the total dosage over the second period of time to areference dosage defined for the second period of time.

In another example, the disclosure relates to a system comprising meansfor receiving a proposed therapy dosing program that defines a fluidtherapy for delivery to a patient via a medical fluid delivery devicefor a first period of time, means for determining a total dosage over asecond period of time, wherein the second period of time at leastpartially overlaps the first period of time, and means for comparing thetotal dosage over the second period of time to a reference dosage.

In another example, the disclosure relates to a non-transitorycomputer-readable storage medium comprising instructions that cause oneor more processors to receive a proposed therapy dosing program thatdefines a fluid therapy for delivery to a patient via a medical fluiddelivery device for a first period of time, determine a total dosageover a second period of time, wherein the second period of time at leastpartially overlaps the first period of time, and compare the totaldosage over the second period of time to a reference dosage.

The details of one or more examples are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram illustrating an example of a fluiddelivery system including an implantable medical device configured todeliver a therapeutic agent to a patient via a catheter.

FIG. 2 is functional block diagram illustrating an example of animplantable fluid delivery device.

FIG. 3 is a functional block diagram illustrating example components ofan external programmer for an implantable medical device.

FIG. 4 is a flow diagram illustrating an example technique forevaluating a proposed therapy program.

FIG. 5 is a conceptual diagram illustrating an example representation ofan example therapy defined by an example therapy dosing program.

FIGS. 6A-6F are conceptual diagrams illustrating an examplerepresentation of an example therapy defined by an example therapydosing program.

FIG. 7 is a conceptual diagram illustrating an example representation ofan example therapy defined by two example therapy dosing programs.

FIG. 8 is a conceptual diagram illustrating an example representation ofa proposed therapy dosing program that may be displayed to a user via anexample user interface.

FIG. 9 is a flow diagram illustrating another example technique forevaluating a proposed therapy program.

DETAILED DESCRIPTION

In general, the disclosure relates to techniques for programming therapydelivered to a patient via a medical fluid delivery device. The therapydelivered to the patient may be delivered by the medical fluid deliverydevice according to one or more therapy dosing programs defined by aclinician or other authorized user. Prior to being used to definetherapy actually delivered to a patient via the medical fluid deliverydevice, one or more processors, e.g., a processor of an externalprogramming device, may evaluate a proposed therapy dosing program thatdefines the delivery of therapy to a patient over a first overall periodof time. In particular, the processor may compare the total dosage of amedical fluid proposed for delivery to a patient during a window of time(or “analysis window”) that overlaps at least a portion of the firstoverall period of time of the therapy program to a reference dosage. Insome examples, the reference dosage used for the comparison may bedefined based on the duration of the analysis window. In some examples,the analysis window may be “swept” across all or portions of the overallperiod of time, in a substantially continuous or incremental manner, toevaluate the therapy defined by the proposed therapy program. In someexamples, an indicator indicative of the comparison may be presented toa user via a user interface of, e.g., a programming device. In someexamples, the processor may determine whether to apply the therapydosage program to define therapy actually delivered to the patient viathe medical fluid delivery device.

Medical fluid delivery devices are useful for treating, managing orotherwise controlling various patient conditions or disorders, such as,but not limited to, pain (e.g., chronic pain, post-operative pain orperipheral and localized pain), tremor, movement disorders (e.g.,Parkinson's disease), diabetes, epilepsy, neuralgia, chronic migraines,urinary or fecal incontinence, sexual dysfunction, obesity,gastroparesis, mood disorders, or other disorders. Some medical fluiddelivery devices may be configured to deliver one or more therapeuticagents, alone or in combination with other therapies, such as electricalstimulation, to one or more target sites within a patient. For example,in some cases, a medical fluid delivery device may deliver insulin to apatient with diabetes. The medical fluid delivery device may beimplanted in the patient for chronic therapy delivery (e.g., longer thana temporary, trial basis) or temporary delivery.

For example, in some cases, a medical fluid delivery device may deliverpain-relieving drug(s) to patients with chronic pain, insulin to apatient with diabetes, or other fluids to patients with differentdisorders. The device may be implanted in the patient for chronictherapy delivery or temporary delivery. For ease of description,examples of the disclosure are primarily described with regard to animplantable fluid delivery device for chronic therapy delivery. However,examples of the disclosure may also be applicable to external fluiddelivery devices or fluid delivery device that are only partiallyimplanted in a patient, e.g., devices including one or morepercutaneously implanted catheters, for chronic or temporary therapydelivery.

An implantable fluid delivery device may deliver one or more therapeuticfluids to a patient according to one or more therapy dosing programs(also referred to herein as “dosing programs”). As used in thisdisclosure, the term therapy dosing program generally refers to aprogram sent to an implantable fluid delivery device by a device forprogramming the implantable fluid delivery device (or preprogrammed onthe implantable fluid delivery device prior to implant) that causes theimplantable fluid delivery device to deliver fluid at a certain rate ata certain time. The dosing program may include, for example, definitionsof a priming bolus, a bridging bolus, a supplemental bolus, and atherapy schedule. A therapy dosing program may include additionalinformation, such as patient information, permissions for a user to adda supplemental bolus, historical therapy schedules, fluid or druginformation, or other information.

A therapy schedule generally defines the rate (which may be zero) atwhich to administer fluid, or a drug or drug combination within thefluid, at a specific time to a patient. In particular, the therapyschedule may define one or more programmed doses, which may be periodicor aperiodic, each dose including a rate and a duration of time overwhich to deliver the desired dose. Rate generally refers to the amountof drug delivered over a period of time, and may change over the courseof a therapy schedule such that a drug may be delivered at differentrates at different times. Although delivery of drugs may be describedfor purposes of illustration, the techniques described in thisdisclosure may be useful in delivery of various therapeutic fluids.Accordingly, description of the delivery of drugs should not beconsidered limiting with respect the techniques broadly described inthis disclosure.

A therapy schedule may include one or more fluid delivery profiles fordetermining the rate of drug delivery at a given time. A fluid deliveryprofile may be graphically represented by plotting the rate of fluiddelivery versus time defined by a therapy schedule for a given period oftime, e.g., hour, day, or week. An example of a fluid delivery profileis illustrated in FIG. 5, which is described further below. In someexamples, to maintain therapeutic efficacy therapy, the rate at whichfluid is delivered to a patient can vary temporally, e.g., rather thanmaintaining a constant rate of fluid delivery over a given time period.Accordingly, a clinician may define one or more therapy schedules for apatient that causes the rate of a fluid delivery being delivery to thepatient to change on a temporal basis. Changes to the rate at whichfluid is delivered to a patient from the implantable medical device maycorrespond to “steps” or “ramps” of a fluid delivery profile.

A priming bolus refers to a bolus delivered by the implantable fluiddelivery device to move the fluid to the distal tip of the catheter,i.e., the tip of the catheter that is remote from the reservoir andinternal tubing, if applicable. Once the fluid is primed to the distaltip of the catheter, the IMD is ready to deliver fluid to the patientfrom the distal tip, e.g., via one or more fluid outlets at or near thedistal tip. The device delivers the priming bolus during a “primingphase” to prepare the device for delivery of fluid to the patient.

An implantable fluid delivery device also may perform a “bridging” boluswhen a new fluid is inserted into a reservoir of the device while an oldfluid is still present in the device, e.g., within internal tubing ofthe device and/or within a catheter connected to the device. Thebridging bolus is performed to define a rate at which to deliver the oldfluid until the old fluid is completely delivered out of the catheterand to the patient such that the device contains only the new fluid. Insome instances, this action by the implantable fluid delivery device maybe referred to as a bridging bolus.

A supplemental bolus is a bolus administered to the patient outside ofthe therapy schedule. The terms independent bolus, one-time bolus, andtherapeutic bolus may also be used in this disclosure to refer to asupplemental bolus. In particular, therapeutic bolus and supplementalbolus may be used generally interchangeably in this disclosure. In oneexample, the implantable fluid delivery device may administer asupplemental bolus before the implantable fluid delivery device beginsadministering doses of fluid according to the therapy schedule. Inanother example, the implantable fluid delivery device may administer asupplemental bolus during the therapy schedule, e.g., to override orsupplement the therapy schedule in response to clinician instruction orpatient request. A supplemental bolus delivered based on a patientrequest may be referred to in some instances as a patient bolus. Thetherapy dosing program may define periods during which the delivery of arequested supplemental therapy bolus is authorized or, conversely, notauthorized.

A clinician or other authorized user may create the one or more therapydosing programs that a fluid delivery device will use to deliver therapyto a patient during an initial programming session. In the case of animplantable fluid delivery device, the initial programming session mayoccur shortly after the device is implanted in the patient. The therapydosing created during the initial programming session may be applied bya processor of the implantable fluid delivery device to define therapyactually delivered to the patient during and after the initialprogramming session. Subsequently, a clinician or other user may modifyone or more of the therapy dosing programs defined during the initialprogramming session and/or create one or more new therapy dosingprograms during one or more follow-up programming sessions.

In either case, the one or more therapy dosing programs created during aprogramming session may be used by a processor of an implantable fluiddelivery device to control therapy delivered to the patient over apredefined period of time. For example, a therapy dosing program may becreated that includes a therapy schedule defining the delivery of a drugto a patient over a 24-hour long period. Such a therapy schedule may bereferred to as a daily therapy schedule in some instances. In otherexamples, a therapy schedule may be defined for period of time with anoverall duration greater than or less than the twenty-four hours.

The total dose delivered to a patient, as defined by a therapy schedule,over the entire time period of the therapy schedule may be determined toevaluate whether or not an acceptable amount of therapeutic fluid willbe delivered to a patient during the period of the therapy schedule. Forexample, for a daily therapy schedule, the total daily dose delivered tothe patient over the 24-hour period may be determined. In some case, thetotal daily dose may be an acceptable amount to effectively treat apatient disorder. In other cases, the total daily dose may reflect thedelivery of an excessive or insufficient amount of therapeutic fluid toa patient, which could result in an overdose or underdose, respectively,during the 24-hour period. In such a case, a clinician may adjust thetherapy schedule as required for the total daily dose delivered to thepatient to be an acceptable amount prior to programming the implantablemedical fluid delivery device with the daily therapy schedule.

However, while the total dose delivered to a patient over the durationof a daily therapy schedule may be an acceptable amount, in somecircumstances, there may be one or more discrete, shorter periods oftime within the 24-hour period during which an excessive or insufficientdose may be programmed for delivery to a patient relative to the shorterperiod of time. Moreover, when a daily therapy schedule is repeated todefine therapy over, e.g., a 48-hour period, there may be a period oftime including a portion of the end of the first daily therapy scheduleand a portion of the beginning of the following daily therapy scheduleduring which an unacceptable dose may be programmed for delivery to thepatient. Such circumstances may be further complicated by thepossibility for a supplemental bolus or other bolus to be delivered atone or more points in time outside that defined by a daily therapyschedule.

In accordance with one or more examples of the disclosure, a processormay be configured to evaluate a proposed therapy dosing program withinone or more analysis windows that at least partially overlap the overallperiod of time of the proposed therapy dosing program. To evaluate theproposed therapy dosing program, the total dose defined for deliverywithin the analysis window may be determined, and then compared to areference dosage, e.g., a reference dosage range acceptable for deliveryto the patient over the duration of second time period. The total dosagedelivered during the analysis window may be determined based only atherapy schedule of the proposed dosing program, or may be determinedbased on both on the therapy schedule in addition to possiblesupplemental boluses and/or other boluses that may be delivered duringthe analysis window. The possible delivery of supplemental and/or otherboluses defined during the analysis window may also be defined by theproposed therapy dosing program. In some examples, based on thecomparison, the processor may apply the proposed therapy dosage programfor actual delivery of therapy to the patient by an implantable fluiddelivery device, e.g., if the total dosage is determined to be withinthe reference dosage range. In some examples, an indicator indicative ofthe comparison may be presented to a user via a user interface, e.g., anindicator indicative of the total dosage being outside the referencedosage range.

As an illustration of one example of the disclosure, in the case of aproposed therapy dosing program including a therapy schedule thatdefines the delivery of a drug to a patient over the period oftwenty-four hours, a processor of a device (e.g., a processor of anexternal programmer) may determine the total dose that would bedelivered to the patient during one or more two-hour analysis windowsoverlapping at least a portion of the daily therapy schedule. The one ormore total doses determined within the analysis windows may then each becompared to a reference dose. In some examples, the reference dose mayinclude an acceptable total dose for delivery to a patient during atwo-hour period of time. If the comparison indicates that the total dosedetermined for all of the analysis windows are acceptable (e.g., beingwithin the reference dosage range), the processor may apply the proposedtherapy dosing program to define therapy delivered to the patient atthat time or some point in the future.

However, if the comparison indicates that the total dose determined forone or more of the analysis windows is unacceptable (e.g., being outsidethe reference dosage range), the processor may present an indicator viaa user interface alerting a programming clinician or other user that thetotal dosage for one or more of the analysis window is outside thereference dosage range and may be undesired. In view of the indicator,the clinician may either modify the dosing program, replace the proposeddosing program with another dosing program, or proceed to program theimplantable fluid delivery device with the dosing program (e.g., ifhe/she determines that there is actually no excessive/insufficient doserisk). In some examples, the programming device may display a graphicalrepresentation of the proposed therapy dosing program with one or moreanalysis window of interest highlighted to allow the clinician tovisualize the proposed therapy and determine how to proceed.

FIG. 1 is a conceptual diagram illustrating an example of a therapysystem 10, which includes implantable medical device (IMD) 12 andcatheter 18. IMD 12 configured to deliver at least one therapeuticagent, such as a pharmaceutical agent, insulin, pain relieving agent,anti-inflammatory agent, gene therapy agent, or the like, to a targetsite within patient 16 via catheter 18, which is coupled to IMD 12.Therapy system 10 also includes external programmer 20, which wirelesslycommunicates with IMD 12 as needed, such as to provide or retrievetherapy information or control aspects of therapy delivery (e.g., modifythe therapy parameters, turn IMD 12 on or off, and so forth). Whilepatient 16 is generally referred to as a human patient, other mammalianor non-mammalian patients are also contemplated.

Generally, IMD 12 has an outer housing that is constructed of abiocompatible material that resists corrosion and degradation frombodily fluids, such as titanium or biologically inert polymers. IMD 12may be implanted within a subcutaneous pocket close to the therapydelivery site. For example, in the example shown in FIG. 1, IMD 12 isimplanted within an abdomen of patient 16. In other examples, IMD 12 maybe implanted within other suitable sites within patient 16, which maydepend, for example, on the target site within patient 16 for thedelivery of the therapeutic agent.

Catheter 18 may be coupled to IMD 12 either directly or with the aid ofa catheter extension (not shown in FIG. 1). In the example shown in FIG.1, catheter 18 traverses from the implant site of IMD 12 to one or moretarget sites proximate to spine 14. Catheter 18 is positioned such thatone or more fluid delivery outlets of catheter 18 are proximate to theone or more target tissue or nerve sites within patient 16. IMD 12delivers a therapeutic agent to the one or more target tissue or nervesites proximate to spinal cord 14 with the aid of catheter 18. Forexample, IMD 12 may be configured for intrathecal drug delivery into theintrathecal space or epidural space surrounding spinal cord 14. Theintrathecal space is within the subarachnoid space of spinal cord 14,which is past the epidural space and dura mater and through the theca ofspinal cord 14. While the target site in FIG. 1 is proximate to spinalcord 14 of patient 16, other target sites are contemplated.

In some examples, multiple catheters 18 may be coupled to IMD 12 totarget the same or different tissue or nerve sites within patient 16.Thus, although a single catheter 18 is shown in FIG. 1, in otherexamples, system 10 may include multiple catheters or catheter 18 maydefine multiple lumens for delivering different therapeutic agents topatient 16 or for delivering a therapeutic agent to different tissuesites within patient 16. Accordingly, in some examples, IMD 12 mayinclude a plurality of reservoirs for storing more than one type oftherapeutic agent. In some examples, IMD 12 may include a single longtube that contains the therapeutic agent in place of a reservoir.However, for ease of description, an IMD 12 including a single reservoiris primarily discussed herein with reference to the example of FIG. 1.

Therapy system 10 may be used, for example, to reduce pain experiencedby patient 16. IMD 12 may deliver one or more therapeutic agents topatient 16 according to one or more therapy dosing programs that setforth different therapy parameters, such as a therapy schedulespecifying programmed doses, rates for the programmed dose, and specifictimes to deliver the programmed doses. The dosing programs may be may bea part of a program group for therapy, where the group includes aplurality of therapy schedules. In some examples, IMD 12 may beconfigured to deliver a therapeutic agent to patient 16 according todifferent therapy schedules on a selective basis. IMD 12 may include amemory to store one or more therapy dosing programs, instructionsdefining the extent to which patient 16 may adjust therapy parameters,switch between dosing programs, or undertake other therapy adjustments.Patient 16 or a clinician may select and/or generate additional dosingprograms for use by IMD 12 via external programmer 20 at any time duringtherapy or as designated by the clinician.

Programmer 20 is an external computing device that is configured towirelessly communicate with IMD 12. For example, programmer 20 may be aclinician programmer that the clinician uses to communicate with IMD 12.Alternatively, programmer 20 may be a patient programmer that allowspatient 16 to view and modify therapy parameters. The clinicianprogrammer may include additional or alternative programming featuresthan the patient programmer. For example, more complex or sensitivetasks may only be allowed by the clinician programmer to prevent patient16 from making undesired changes to the operation of IMD 12.

Programmer 20 may be a hand-held computing device that includes adisplay viewable by the user and a user input mechanism that can be usedto provide input to programmer 20. For example, programmer 20 mayinclude a display screen (e.g., a liquid crystal display or a lightemitting diode display) that presents information to the user. Inaddition, programmer 20 may include a keypad, buttons, a peripheralpointing device, touch screen, voice recognition, or another inputmechanism that allows the user to navigate through the user interface ofprogrammer 20 and provide input.

In other examples, rather than being a handheld computing device or adedicated computing device, programmer 20 may be a larger workstation ora separate application within another multi-function device. Forexample, the multi-function device may be a cellular phone, personalcomputer, laptop, workstation computer, or personal digital assistantthat can be configured to an application to simulate programmer 20.Alternatively, a notebook computer, tablet computer, or other personalcomputer may enter an application to become programmer 20 with awireless adapter connected to the personal computer for communicatingwith IMD 12.

In some cases, programmer 20 may also be configured for use by patient16. When configured as the patient programmer, programmer 20 may havelimited functionality in order to prevent patient 16 from alteringcritical functions or applications that may be detrimental to patient16. In this manner, programmer 20 may only allow patient 16 to adjustcertain therapy parameters or set an available range for a particulartherapy parameter. In some cases, a patient programmer may permit thepatient to control IMD 12 to deliver a supplemental, patient bolus, ifpermitted by the applicable therapy dosing program administered by theIMD, e.g., if delivery of a patient bolus would not violate a lockoutinterval or maximum dosage limit. Programmer 20 may also provide anindication to patient 16 when therapy is being delivered or when IMD 12needs to be refilled or when the power source within programmer 20 orIMD 12 need to be replaced or recharged.

When programmer 20 is configured for use by the clinician, programmer 20may be used to transmit initial programming information to IMD 12. Thisinitial information may include hardware information for system 10 suchas the type of catheter 18, the position of catheter 18 within patient16, the type of therapeutic agent(s) delivered by IMD 12, a baselineorientation of at least a portion of IMD 12 relative to a referencepoint, one or more therapy dosing programs stored within IMD 12 orwithin programmer 20, and any other information the clinician desires toprogram into IMD 12.

A clinician may use programmer 20 to program IMD 12 with one or moretherapy dosing programs that define the therapy delivered by IMD 12 topatient 16. During a programming session, the clinician may propose oneor more therapy dosing programs that may provide effective therapy topatient 16. Programmer 20 may assist the clinician in thecreation/identification of therapy dosing programs by providing amethodical system of identifying potentially beneficial therapyparameters.

A proposed therapy dosing may set forth therapy parameters, such asdifferent predetermined dosages of the therapeutic agent (e.g., a doseamount), the rate of delivery of the therapeutic agent (e.g., rate ofdelivery of the fluid), the maximum acceptable dose, a time intervalbetween successive supplemental boluses such as patient-initiatedboluses (e.g., a lock-out interval), a maximum dose that may bedelivered over a given time interval, and so forth. As noted above, atherapy dosing program may include one or more therapy schedules thatdefine one or more programmed doses, where each dose includes a rate andduration of time over which to deliver the desired dose, for apredefined duration of time (e.g., a 24-hour period). A therapy dosingprogram may also include information regarding supplemental boluses,including information defining when the delivery of a supplemental bolusis authorized.

In accordance with the techniques described herein, one or moreprocessors of programmer 20, IMD 12, and/or other device may beconfigured to evaluate a proposed therapy dosing program prior to beingapplied by IMD 12 to define therapy delivered to patient 16. Forexample, for a proposed therapy dosing program defining therapy over afirst period of time, such processor(s) may determine the total dosedefined for delivery by the therapy dosing program for one or moreanalysis windows that overlap at least a portion of the first durationof time. The total dose determined for each analysis window may becompared to a reference dosage defined for the time period of theanalysis window. In some examples, based on the comparison, the one ormore processors of the device(s) may determine apply the proposedtherapy dosing program to define therapy actually delivered to patient16 via IMD 12.

Whether programmer 20 is configured for clinician or patient use,programmer 20 may communicate to IMD 12 or any other computing devicevia wireless communication. Programmer 20, for example, may communicatevia wireless communication with IMD 12, e.g., using radio frequency (RF)telemetry techniques known in the art. Programmer 20 may alsocommunicate with another programmer or computing device via a wired orwireless connection using any of a variety of local wirelesscommunication techniques, such as RF communication according to the802.11 or Bluetooth specification sets, infrared (IR) communicationaccording to the IRDA specification set, or other standard orproprietary telemetry protocols. Programmer 20 may also communicate withanother programming or computing device via exchange of removable media,such as magnetic or optical disks, or memory cards or sticks. Further,programmer 20 may communicate with IMD 12 and another programmer viaremote telemetry techniques known in the art, communicating via a localarea network (LAN), wide area network (WAN), public switched telephonenetwork (PSTN), or cellular telephone network, for example.

In applications of therapy system 10, catheter 18 may be configured todeliver therapy agents from IMD 12 to one or more target sites ofpatient 16. In some examples, catheter 18 may be positioned to deliverone or more therapeutic agents to the intrathecal space or other sitesproximate to the spinal cord of a patient, e.g., to influence nerves ofthe spinal cord. In some examples, the target delivery site may beproximate to different types of tissues including, e.g., sacral,pudendal or perineal nerves, organs, muscles or muscle groups. Asanother example, catheter 18 may be positioned to deliver a therapeuticagent to a deep brain site, vasculature, or within the heart (e.g.,intraventricular delivery of the agent). Delivery of a therapeutic agentwithin the brain may help manage any number of disorders or diseases.Example disorders may include depression or other mood disorders,dementia, obsessive-compulsive disorder, migraines, obesity, andmovement disorders, such as Parkinson's disease, spasticity, andepilepsy. Catheter 18 may also be positioned to deliver insulin to apatient with diabetes.

Examples of therapeutic agents that IMD 12 may be configured to deliverinclude, but are not limited to, insulin, morphine, hydromorphone,bupivacaine, clonidine, other analgesics, genetic agents, antibiotics,nutritional fluids, analgesics, hormones or hormonal drugs, gene therapydrugs, anticoagulants, cardiovascular medications or chemotherapeutics.

FIG. 2 is a functional block diagram illustrating components of anexample of IMD 12, which includes refill port 26, reservoir 30,processor 38, memory 40, telemetry module 42, power source 44, fluiddelivery pump 46, internal tubing 32, and catheter access port 36. Fluiddelivery pump 46 may be a mechanism that delivers a therapeutic agent insome metered or other desired flow dosage to the therapy site withinpatient 16 from reservoir 30 via the catheter 18. Refill port 26 maycomprise a self-sealing membrane to prevent loss of therapeutic agentdelivered to reservoir 30 via refill port 26. After a delivery system,e.g., a hypodermic needle, penetrates the membrane of refill port 26,the membrane may seal shut when the needle is removed from refill port26.

Internal tubing 32 is a segment of tubing that runs from reservoir 30,around or through fluid delivery pump 46, to catheter access port 36. Inone example, fluid delivery pump 46 may be a squeeze pump that squeezesinternal tubing 32 in a controlled manner, e.g., such as a peristalticpump, to progressively move fluid from reservoir 30 to the distal end ofcatheter 18 and then into the patient according to parameters specifiedby a set of program information. Fluid delivery pump 46 may, in otherexamples, comprise an axial pump, a centrifugal pump, a pusher plate, apiston-driven pump, or other means for moving fluid through internaltubing 32 and catheter 18.

Processor 38 controls the operation of fluid delivery pump 46 with theaid of instructions associated with program information that is storedin memory 40. For example, the instructions may define dosing programsthat specify the amount of a therapeutic agent that is delivered to atarget tissue site within patient 16 from reservoir 30 via catheter 18.The instructions may further specify the time at which the agent will bedelivered and the time interval over which the agent will be delivered.The amount of the agent and the time over which the agent will bedelivered are a function of the dosage rate at which the fluid isdelivered. The therapy programs may also include other therapyparameters, such as the frequency of bolus delivery, the type oftherapeutic agent delivered if IMD 12 is configured to deliver more thanone type of therapeutic agent), and so forth. Components described asprocessors within IMD 12, external programmer 20, or any other devicedescribed in this disclosure may each comprise one or more processors,such as one or more microprocessors, digital signal processors (DSPs),application specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), programmable logic circuitry, or the like, eitheralone or in any suitable combination.

Memory 40 may include any volatile or non-volatile media, such as arandom access memory (RAM), read only memory (ROM), non-volatile RAM(NVRAM), electrically erasable programmable ROM (EEPROM), flash memory,and the like. As mentioned above, memory 40 may store programinformation including instructions for execution by processor 38, suchas, but not limited to, therapy programs, historical therapy programs,timing programs for delivery of fluid from reservoir 30 to catheter 18,and any other information regarding therapy of patient 16. A program mayindicate the bolus size or flow rate of the drug, and processor 38 mayaccordingly deliver therapy. Memory 40 may include separate memories forstoring instructions, patient information, therapy parameters (e.g.,grouped into sets referred to as “dosing programs” or “therapy dosingprograms”), therapy adjustment information, program histories, and othercategories of information such as any other data that may benefit fromseparate physical memory modules. Therapy adjustment information mayinclude information relating to timing, frequency, rates and amounts ofpatient boluses or other permitted patient modifications to therapy. Insome examples, memory 40 stores program instructions that, when executedby processor 38, cause IMD 12 and processor 38 to perform the functionsattributed to them in this disclosure.

Memory 40 may be considered, in some examples, a non-transitorycomputer-readable storage medium comprising instructions that cause oneor more processors, such as, e.g., processor 38, to implement one ormore of the example techniques described in this disclosure. The term“non-transitory” may indicate that the storage medium is not embodied ina carrier wave or a propagated signal. However, the term“non-transitory” should not be interpreted to mean that memory 40 isnon-movable. As one example, memory 40 may be removed from IMD 14, andmoved to another device. In certain examples, a non-transitory storagemedium may store data that can, over time, change (e.g., in RAM).

Telemetry module 42 in IMD 12, as well as telemetry modules in otherdevices described herein, such as programmer 20, may accomplishcommunication by RF communication techniques. In addition, telemetrymodule 42 may communicate with programmer 20 via proximal inductiveinteraction of IMD 12 with external programmer 20. Accordingly,telemetry module 42 may send information to external programmer 20 on acontinuous basis, at periodic intervals, or upon request from theprogrammer. Processor 38 controls telemetry module 42 to send andreceive information. Wireless telemetry may be accomplished by RFcommunication or proximal inductive interaction of IMD 12 with externalprogrammer 20.

Power source 44 delivers operating power to various components of IMD12. Power source 44 may include a small rechargeable or non-rechargeablebattery and a power generation circuit to produce the operating power.

FIG. 3 is a functional block diagram illustrating various components ofan external programmer 20 for IMD 12. As shown in FIG. 3, externalprogrammer 20 includes processor 84, memory 86, telemetry module 88,user interface 82, and power source 90. A clinician or patient 16interacts with user interface 82 in order to manually change theparameters of a therapy dosing program, change therapy dosing programswithin a group of programs, view therapy information, view historicaltherapy regimens, establish new therapy regimens, or otherwisecommunicate with IMD 12 or view programming information.

User interface 82 may include a screen and one or more input buttonsthat allow external programmer 20 to receive input from a user.Alternatively, user interface 82 may additionally or only utilize atouch screen display, as in the example of clinician programmer 60. Thescreen may be a liquid crystal display (LCD), dot matrix display,organic light-emitting diode (OLED) display, touch screen, or any otherdevice capable of delivering and/or accepting information. For visibleindications of dosing program parameters or operational status, adisplay screen may suffice. For audible and/or tactile indications ofdosing program parameters or operational status, programmer 20 mayfurther include one or more audio speakers, voice synthesizer chips,piezoelectric buzzers, or the like.

Processor 84 controls user interface 82, retrieves data from memory 86and stores data within memory 86. Processor 84 also controls thetransmission of data through telemetry module 88 to IMD 12. Thetransmitted data may include therapy dosing program informationspecifying various drug delivery program parameters. Memory 86 mayinclude operational instructions for processor 84 and data related totherapy for patient 16. In some examples, memory 86 may storeinformation defining reference dosages defined for respective analysiswindows and other information that may be used by processor 84 toevaluate proposed therapy dosing programs according to one or moreexamples of the disclosure.

User interface 82 may be configured to present dosing programinformation to the user. User interface 82 enables a user to program IMD12 in accordance with one or more dosing programs, e.g., programs thatdefine a therapy schedule for delivering programmed doses of fluid, apriming bolus, a therapeutic bolus, a bridging process, or similarinformation. A user such as a clinician, physician or other caregivermay input patient information, drug information, therapy deliveryschedules, priming information, bridging information, drug/IMD implantlocation information, or other information to programmer 20 via userinterface 82. In addition, user interface 82 may display dosing programinformation as graphical bar graphs or charts, numerical spread sheets,or in any other manner in which information may be displayed.

Telemetry module 88 allows the transfer of data to and from IMD 12.Telemetry module 88 may communicate automatically with IMD 12 at ascheduled time or when the telemetry module detects the proximity of IMD12. Alternatively, telemetry module 88 may communicate with IMD 12 whensignaled by a user through user interface 82. To support RFcommunication, telemetry module 88 may include appropriate electroniccomponents, such as amplifiers, filters, mixers, encoders, decoders, andthe like. Power source 90 may be a rechargeable battery, such as alithium ion or nickel metal hydride battery. Other rechargeable orconventional batteries may also be used. In some cases, externalprogrammer 20 may be used when coupled to an alternating current (AC)outlet, i.e., AC line power, either directly or via an AC/DC adapter.

As described above, some examples of the disclosure relates totechniques for evaluating a proposed therapy dosing program. In someexamples, to evaluate a proposed therapy dosing program, the total doseproposed for delivery during each of one or more discrete periods oftime (or “analysis windows”) at least partially overlapping the overallperiod of time for which a therapy dosing program defines therapy may bedetermined. Once determined, such total doses may be compared to areference dose defined for the duration of the analysis window. Based onthe comparison, a proposed therapy program may be, for example, appliedto define therapy actually delivered to patient 16 via IMD 12, orrejected.

FIG. 4 is a flow diagram illustrating one example technique forevaluating a proposed therapy dosing program. For purposes ofillustration, the example technique will be described with regard totherapy system 10 (FIG. 1), although other therapy systems arecontemplated. The example technique of FIG. 4 may be implemented priorto applying a proposed therapy dosing program to define therapy actuallydelivered to patient 14 via IMD 12. For example, such an exampletechnique may be utilized during a programming session during which oneor more therapy dosing programs are defined by a clinician forcontrolling the therapy delivered by IMD 12 to patient 16 once applied.In this manner, such an example technique may be used to screen aproposed therapy program to identify windows of time within the overalltime duration of the proposed therapy program where an undesirableamount (e.g., excessive or insufficient) could potentially beadministered to patient 16 if the therapy dosing program were to beapplied to define therapy delivered via IMD 12.

In one example, a single proposed therapy program may be evaluated bythe example technique of FIG. 4. In other examples, multiple proposedtherapy dosing programs proposed to be delivered consecutively may beevaluated using such a technique, with the analysis window overlappingat least a portion of each of the proposed therapy dosing programs. Forexample, as described with regard to FIG. 7 below, for two proposedtherapy dosing programs delivered consecutively, such an evaluation maybe used to identify time periods during which a potentially unacceptabledose may be programmed for delivery to the patient resulting from theproposed combination of first and second therapy dosing programs. Thismay be the case even if there are no time periods during the firsttherapy dosing program and the second therapy dosing program, whenevaluated individually, for which the total dosage within the analysiswindow is outside that of the reference dosage range.

For ease of illustration, the example technique of FIG. 4 is describedwith regard to processor 84 of external programmer 20 receiving andanalyzing a proposed therapy dosing program. However, examples are notlimited to such a configuration, and processor of one or more devicesmay be utilized to perform all or portions of the techniques in additionto or in lieu of that of processor 84 of programmer 20. For example,processor 38 of IMD 12 may perform all or a portion of the exampletechnique of FIG. 4 in combination with or instead of processor 84.

As shown in FIG. 4, processor 84 receives information defining aproposed therapy dosing program (92). The proposed therapy programreceived by processor 84 may be defined, for example, by a clinician orother user during or prior to the programming session. After receivingthe information defining a proposed therapy dosing program (92),processor 84 may determine the overall time period of the proposedtherapy dosing program (94). The overall or total time period of aproposed therapy dosing program may be equal to that of the total timeelapsed from the first point at which a rate is defined by a therapyschedule to the last point that a rate is defined by a therapy schedule.For example, a proposed therapy dosing program that includes a dailytherapy schedule, processor 84 may determine the overall time period ofthe proposed therapy dosing program is twenty-four hours.

After receiving the proposed therapy dosing program (92) and determiningthe overall time period of the proposed therapy dosing program (94),processor 84 may determine the total dosage proposed for delivery topatient 16 within each of one or more analysis windows (96) for theproposed therapy dosing program. The one or more analysis windows usedby processor 84 may correspond to a substantially continuous period oftime that at least partially overlaps the overall time period of theproposed therapy dosing program. In some examples, the analysis windowmay be a period of time substantially entirely within the overall timeperiod of the proposed therapy dosing program. For example, for atherapy dosing program defining therapy delivery over a twenty-four hourperiod of time, the analysis window may be defined by a time period ofless than twenty-four hours (e.g., a two hour analysis window). In thecase of a two hour analysis window, as one example, processor 84 mayevaluate the proposed therapy dosing program temporally in two hourblocks of time overlapping the overall time period. Such an example isdescribed further below with regard to FIG. 5. In some examples, theduration of the analysis window is less than the duration of the overalltime period of the proposed therapy dosing program.

Processor 84 may determine the total dosage within the analysis window(96) based on the duration and rate of each dose defined by the proposedtherapy dosing program during the period of time being evaluated. In thecase of a therapy dosing program represented as a plot of rate versustime, the total dosage within an analysis window would be approximatelyequal to the total area under the plot during the particular time periodof the analysis window.

Processor 84 may determine that total dosage for a single analysiswindow or multiple different analysis windows at least partially (e.g.,substantially entirely) overlapping the overall time period of theproposed therapy dosing program (96). For each analysis window,processor 84 may compare the total dosage to a reference dosage (98). Insome examples, the reference dosage may generally define the dosage thatis acceptable for delivery to a patient in view of the duration of theanalysis window. In the example, of FIG. 4, the reference dosage used tocompare to the total dosage for each analysis window includes a range ofdosage values, the bounds of which may be defined by a lower thresholddosage value and an upper threshold dosage value. In some examples, thelower threshold dosage value may be zero or some value other than zero.In some examples, the upper threshold value may be a specific value ordefined as any value greater than zero. In some examples, the referencedosage may be defined as zero, e.g., for cases in which it is desiredfor no dosage to be delivered to a patient over the duration of theanalysis window.

As will be described further below, processor 84 may take any of avariety of steps based on the comparison (98). FIG. 9 is a flow chartillustrating one example for evaluating a proposed therapy program. Asdescribed with regard to FIG. 4, after receiving the proposed therapydosing program (92) and determining the overall time period of theproposed therapy dosing program (94), processor 84 may determine thetotal dosage proposed for delivery to patient 16 within each of one ormore analysis windows (96) for the proposed therapy dosing program.Processor 84 may then compare each of the determined total dosages tothe reference dosage range (98).

If the total dosage determined to each analysis window is within thereference dosage range, processor 84 may apply the proposed therapyprogram (100), e.g., by transmitting the proposed therapy dosing programto IMD 12 via telemetry module 88 (FIG. 3). Processor 38 of IMD 12 maystore the proposed therapy program 40 in memory 40, and access theproposed therapy program 40 to control the delivery of the therapeuticagent to patient 16, e.g., to treat a patient condition. In particular,as shown in FIG. 4, processor 38 may control pump 46 to deliver therapyaccording to the therapy dosing program (101). In some examples,processor 84 may automatically apply the proposed therapy program basedon the comparison (98), or may do so after receiving approval from auser via user interface 82 to apply the program. In some example, suchuser input is prompted in combination with an indicator indicating theresults of the comparison displayed via user interface 82. Such anindicator may be presented to a user via user interface 82 even if userapproval for application of the proposed therapy program is notrequired.

As another example, if the total dosage determined for any of theanalysis window is outside the reference dosage range (above or belowthe reference dosage range), processor 84 may not directly apply theproposed therapy dosing program. By not applying the proposed therapydosing program, processor 84 may prevent, at least temporarily, IMD 12from using the proposed therapy dosing program to define therapyactually delivered to patient 16. As shown in FIG. 9, in some examples,processor 84 may generate an alert, message or other indicator (e.g.,via user interface 82) indicating to the user that the proposed therapyprogram defines a total dosage within one or more analysis windows thatis outside the reference dosage range rather than transmitting theproposed therapy program to IMD 12 (102). Based on such an indicator, auser may decide, for example, to modify the proposed therapy dosingprogram, replace the proposed therapy, dosing program with anotherdosing program, or proceed to program the implantable fluid deliverydevice with the dosing program (e.g., if the user determines that thereis actually no excessive/insufficient dose risk).

FIG. 5 is a conceptual diagram illustrating example representation of anexample therapy defined by an example therapy dosing program. Forpurposes of illustration, the example technique of FIG. 4 will befurther described with regard to the proposed therapy programrepresented by FIG. 5. As shown, the overall time period of the proposeddosing program represented in FIG. 5 is approximately twenty-four hours.For reference, time is shown on the horizontal axis running fromapproximately midnight to midnight. However, the proposed therapy dosingprogram could be used by IMD 12 to define the delivery of therapy topatient 16 for any twenty-four hour period. Moreover, other exampleproposed therapy dosing programs may define overall time periods thatare less or greater than twenty-four hours.

As described above, a proposed therapy dosing program may include both atherapy schedule as well an information regarding the authorization forthe delivery of supplemental boluses (e.g., a patient requestsupplemental bolus) and/or any other type bolus. In the example of FIG.5, solid line 104 represents the rate and duration defined by a therapyschedule of the proposed therapy dosing program. Dashed line 106represents the rate and duration in the event that the therapy scheduleis combined with a potential supplemental bolus. As such, the differencein rate between line 104 and line 106 represents the increase in ratewhen a supplemental bolus is delivered to patient 16 outside of thetherapy schedule. While in practice, it may not be possible to deliver asupplemental bolus throughout the entire twenty-four hour time period(e.g., due to supplemental bolus authorization lock-outs), processor 84may use such an increased rate when evaluating a proposed therapy dosingprogram as the particular time at which a supplemental bolus isdelivered, e.g., in response to a patient request, may not be known whenthe proposed therapy dosing program in being evaluated.

Processor 84 may utilize analysis window 108 to evaluate the proposedtherapy dosing program of FIG. 5. As shown, analysis window 108 has aduration of approximately two hours, although other analysis windowswith durations other than two hours are contemplated. The duration ofanalysis window 108 may be adjustable by a user, such as a clinician orother caregiver, during a programming session and/or may be apreprogrammed value. In some examples, the duration of an analysiswindow may be some default value based on the overall duration of aproposed therapy program. For example, the duration of analysis window108 may be some percentage (e.g., approximately 10 percent) of theoverall duration of a proposed therapy program.

According to the example of FIG. 4, after receiving the proposed therapydosing program 92, processor 84 may determine the total dosage proposedfor delivery to patient 16 via IMD 12 during analysis window 108 (96),and then compare the total dosage proposed for delivery to a referencedosage. The reference dosage may be defined to correspond to theduration of analysis window 108, which in the case of the example ofFIG. 5 is approximately two hours. In such an example, the referencedosage used by processor 84 may generally reflect a total dosage overtwo hours (or whatever the duration of the analysis window) that isbelieved to effectively treat the condition of patient 16 but not resultin any undesirable side effects due to excessive or insufficientdelivery of therapeutic fluid to patient 16 over two hours. Such areference dosage may be patient and/or drug specific, and may be definedby a clinician and/or supplier of the therapeutic fluid delivered topatient 16 via IMD 12. A clinician may manually input the referencedosage value or range or such a reference dosage may be automaticallyset. As described above, a reference dosage range may be defined interms of an upper limit, a lower limit, or both for the duration of theanalysis window.

In some examples, a reference dosage may be provided on labeling orother material provided by a medical device manufacturer for a certaintherapy (e.g. for pain therapy) or “on label” for, e.g., delivery ofMorphine (as an alternate e.g. for Baclofen for spasticity).Alternatively or additionally, a clinician may develop his/her ownprotocols governing what he/she considers a “reasonable” dosage range orapproach to dosing as a broader policy (applicable to all patients). Aclinician may make patient specific decisions, e.g., based on thehistory and status of the patient (e.g. in a cancer pain case, as thepatient has increasing tolerance over time, a reference dosage range mayincrease over time) with regard to reference dosage. Alternatively oradditionally, a certain set of guidelines published by a group ofexperts (such as in a journal or the proceedings of a conference) may beused to define the reference dosage for a particular time period.Alternatively or additionally, a medical device manufacturer or anotherparty familiar with the clinical use of such systems may empiricallymodel the “normal” range of difference in dosage between any given timehour period (e.g., two hours) and a patients average daily rate (perhapseven for a specific drug or admixture), and then provide guidance to auser at to that normal range of change (e.g., a certain percentage ornumber of mg (or other unit) of drug increase/decrease).

In some examples, it may be possible to identify an approximatemathematical relationship which takes such factors as the daily dose,drug information and/or duration of a shorter analysis window as inputsand provides a reasonable range of change output to define a referencedosage range. Even if such an equation was defined to be fairlyconservative, it may still pick up certain kinds of dosing programmingerrors (such as, e.g., defining a patient bolus or step that has a muchhigher dose than it was intended to because of order of magnitudeerrors).

As the reference dosage values may be specific to the duration ofanalysis window, the reference dosage for an analysis window of a firstduration may be different than the reference dosage for an analysiswindow of a second duration.

In some cases, the reference dosage may be defined based at least inpart on the total dosage delivered over the entire time period of theproposed therapy. For example, the reference dosage may be defined asthe percentage of the total dosage proposed for delivery over the entiretime period of the proposed therapy dosing program, where the percentageis approximately equal to the percentage that the duration of theanalysis window is of the overall duration of the proposed therapydosing program. For example, in the case of the example shown in FIG. 5,the reference dosage value may be defined as approximately 8.34% (orapproximately 1/12) of the total dosage proposed for delivery over theentire time period of the therapy dosing program. In FIG. 5, the totaldosage proposed for delivery over the entire time period, according toonly the proposed therapy schedule, may be approximately equal to thetotal area under line 104. Alternatively, the total dosage for deliveryover the entire time period, according to the proposed therapy schedulein combination with the potential for delivery of one or moresupplemental boluses, may be approximately equal to the total area underline 106. In either case, such a value may be used alone as thereference dosage value or may be used to define a referenced dosagerange using such a value as a baseline. For example, the referencedosage range may be defined as any dosage within, for example, 25% ofthe dosage value (above and/or below) calculated as described above.

Regardless of the particular reference dosage defined for the durationof analysis window 108, processor 84 may compare the total dosageproposed for delivery within analysis window 108 to the reference dosage(98). As described above, in some examples, processor 84 may determinewhether to apply the proposed therapy program based on the comparison.In particular, if the reference dosage is defined by a range of valuesthat are acceptable for delivery to patient 16 over the duration ofanalysis window 108, processor 84 may apply the proposed therapy programif the total dosage proposed for delivery during analysis window 108 iswithin the range. After being applied, processor 38 may deliver therapyto patient 16 according to the therapy dosing program. In some cases,the proposed therapy may undergo further evaluation prior to actuallybeing utilized by processor 38 to control the delivery of therapeuticfluid to patient 16 via IMD 12.

In some examples, when a proposed therapy program has been applied byprocessor 84, processor 84 may transmit information defining theproposed therapy dosing program to IMD 12. The proposed therapy dosingprogram may then be stored in memory 40, and processor 38 may use theproposed therapy program to control the delivery of therapeutic fluid topatient 16 at some later point in time. Alternatively, the therapydosing program may be stored in memory 86, and processor 38 of IMD 12may access the therapy dosing program via telemetry as needed to controlthe delivery of therapeutic fluid to patient 16. In some examples, onlyproposed therapy dosing programs that have been applied by processor 84after being evaluated according to the example technique of FIG. 4, orsome variations thereof, may be used by IMD 12 to define therapydelivered to patient 16 via IMD 12.

In some examples, if processor 84 determines that the total dosagewithin analysis window 108 is outside the reference dosage range,processor 84 may not directly apply the proposed therapy dosing program.If processor 84 does not apply a proposed therapy dosing program, theproposed therapy dosing program may not be used to define therapydelivered to patient 16 via IMD 12. In some examples, processor 84 maygenerate and display an indicator via user interface 82 indicating to aclinician or other user that a proposed therapy dosing program includesa total dosage during an analysis window that is inconsistent with thereference dosage (e.g., outside the reference dosage range). In thismanner, the user may be informed of the potential issue with theproposed therapy dosing program, and decide what modifications, if any,should be made in view of the rejection of the proposed therapy dosingprogram.

In some examples, a clinician may input a new, proposed therapy dosingprogram in place of a proposed therapy dosing program that has beenrejected, in which case processor 84 may evaluate the new therapy dosingprogram using substantially the same technique that resulted in therejection of the prior proposed therapy dosing program. Alternatively, aclinician may input one or more modifications to the proposed therapydosing program, e.g., via user interface 82 (FIG. 3). For instance, aclinician may adjust the rate (e.g., increase or decrease) and/orduration of the delivery defined by a therapy schedule during at least aportion of the time period for which the total dosage within analysiswindow 108 was determined to be outside the reference dosage range.Alternatively or additionally, a clinician may adjust the authorizationfor supplemental boluses or other supplemental boluses that may bedelivered during the time period of the therapy schedule. In any case,after the rejected proposed therapy dosing program has been modified,processor 84 may again evaluate the proposed therapy dosing programusing substantially the same technique. This process may be repeateduntil processor 84 determines that there is not an analysis windowduring which the total dosage is outside the reference dosage. Processor84 may then apply the proposed therapy dosing program (100), and theproposed therapy dosage program may be used by processor 38 to definethe delivery of therapy to patient 16 via IMD 12 (101).

While the example of FIG. 5 illustrates analysis window 108 asoverlapping a single period of time (i.e., from about 7:45 am to about9:45 am) of the proposed therapy dosing program, analysis window 108 maybe adjusted to overlap any period of time at least partially within theproposed therapy dosing program. Moreover, analysis window 108 may bemoved, in a conceptual sense, to overlap a plurality different periodsof time at least partially within the proposed therapy dosing program.In such a case, processor 84 may determine the total dosage proposed fordelivery to patient 16 for each of multiple different two hour periodsof time (or, more generally, the duration of analysis window 108)overlapping the proposed therapy dosing program, and compare the totaldosage determined for each time period to the reference dosage definedfor the duration of analysis window 108. In some examples, a clinicianmay direct the position of window 108 over a proposed therapy dosingwindow, e.g., based on time periods thought to be of interest.Additionally or alternatively, processor 84 may automatically orsemi-automatically evaluate all or a portion of proposed therapy dosingprogram when received.

As an illustration, in the example of FIG. 5, processor 84 may determinethe total dosage proposed for delivery for each of the time periods from12 am to 2 am, 2 am to 4 am, 4 am to 6 am, and so forth (96), andcompare the total dosage determined for each time period to thereference dosage (98) as described above. In some examples, processor 84may apply the proposed therapy program based on the plurality ofcomparisons. In some examples, the results of the comparison may bepresented to user for evaluation. For example, if processor 84determines that one or more of the total dosages are outside thereference dosage range, processor 84 may alert a user that the totaldosage of one or more analysis windows of the proposed therapy dosingprogram is outside the reference dosage range. Alternatively, ifprocessor 84 determines that none of the total dosages are outside thereference dosage range, processor 84 may apply the proposed therapydosing program to define therapy actually delivered to patient 16 viaIMD 12 or present the results of the comparison to a user and prompt theuser to confirm that the therapy dosing program should be applied.

Processor 84 may use one or more analysis windows in such a fashion toevaluate a portion or substantially all of a proposed therapy dosingprogram. In some examples, processor 84 may analyze substantially all ofthe overall time period of a proposed therapy dosing program by way of aplurality analysis windows having a duration of less than the overalltime period of the proposed therapy dosing program. In this sense,analysis window 108 may moved or “swept” over the entire time period ofthe proposed therapy program to detect any periods of time during whichthe total dosage delivered to patient 16 would be outside the referencedosage range defined for the duration of analysis window 108.

In cases in which processor 84 analyzes a proposed therapy dosingprogram by determining a total dosage during each of a plurality ofanalysis windows, the increments of offset between respective analysiswindows may be less than the duration of the analysis windows. Forexample, for the two hour analysis window 108 in FIG. 5, processor 84may determine a total dosage for analysis windows with the start of eachwindow offset by, for example, approximately 15 minutes (12:00 am, 12:15am, 12:30 am, and so forth). In other examples, the increments of offsetbetween respective analysis windows may be greater than or approximatelyequal to the duration of the analysis windows.

In some examples, processor 84 may incrementally move analysis window108 over all or a portion of a propose therapy dosing program (e.g., inapproximately 1 minutes increments). In some examples, rather thananalyzing substantially the entire duration of a proposed therapyprogram, processor 84 may identify particular areas of interest of atherapy dosing program to evaluate and/or periods during which it isunlikely that the therapy dosing program defines an overall dosage thatis not outside a reference dosage range for the analysis window. Forexample, if the duration of analysis window 108 is relatively small andwindow 108 fits entirely within a period of time where the rate wasconstant (e.g., during the middle of a step or patient bolus), then allthe windows positions within that constant rate would be the same. Insuch a case, processor 84 may only evaluate the boundaries with otherrates and once at some period of time where the rate is constant. Insome examples, the boundaries between relatively long steps may be usedto target the period of time evaluated by analysis window 108. Forexample, if the window is small enough relative to the constant rateperiods that it can only cover one boundary at a time, then processor 84may determine, based on which of the two rates is higher and whetherover or under dose is of interest (or both in two separate passes),which temporal position will produce the “worse” dosage, and notcalculate the boundary or the step/period corresponding to the “better”dose windows.

In addition to adjusting the time period of a proposed therapy dosingprogram being analyzed by processor 84, the duration of analysis window108 may also be adjusted. In some examples, all or portions of aproposed therapy dosing program may be analyzed by processor 84 withmultiple analysis windows each having different durations. In someexamples, processor 84 may evaluate substantially all of the time periodof a proposed dosing program (approximately twenty-four in the exampleof FIG. 5) with a plurality of analysis windows each having a firstduration. Processor 84 may also evaluate substantially all of the timeperiod of a proposed dosing program (approximately twenty-four in theexample of FIG. 5) with a plurality of analysis windows each having asecond duration different than the first duration.

FIGS. 6A-6F are conceptual diagrams illustrating an examplerepresentation of an example therapy defined by an example therapydosing program. The examples of FIG. 6A-6F are used to illustrateexamples in which processor 84 evaluates “worst” case scenarios forproposed therapy dosing programs. Processor 84 may identify the “worst”case scenarios automatically according to the bolus authorizationinformation and therapy schedule defined by a proposed therapy dosingprogram.

In FIGS. 6A-6F, the therapy dosing schedule of the proposed therapydosing program is substantially similar to that of FIG. 5. As shown, theoverall time period of the proposed dosing program represented in FIG. 6is approximately twenty-four hours. For reference, again, time is shownon the horizontal axis running from approximately midnight to midnight.However, the proposed therapy dosing program could be used by IMD 12 todefine the delivery of therapy to patient 16 for any twenty-four hourperiod. Moreover, other example proposed therapy dosing programs maydefine overall time periods that are less or greater than twenty-fourhours.

In the example of FIG. 6A, solid line 105 represents the rate andduration defined by a therapy schedule of the proposed therapy dosingprogram. Box 107 (shown in FIGS. 6B-6F) represents the rate and durationof a single bolus authorized for delivery by the proposed therapy dosingprogram. Unlike that shown in FIG. 5, such a bolus is shown as beingdefined by a fixed rate and period of time, rather than a percentageincrease relative to the therapy schedule rate.

In FIG. 6B, box 107 overlaps the portion the proposed therapy programcorresponding to the “worst” case for the timing of the bolus during theproposed therapy program in term of overdose. In FIG. 6C, the durationof analysis window 108 is just longer than the duration of theauthorized bolus 107. Analysis window 108 is shown overlapping this“worst” case such that the total dosage during the analysis windowcorresponds to the maximum dosage that patient 12 may be delivered byIMD 12 (in the case where a single bolus is authorized during a 24-hourperiod). Using the techniques described in this disclosure, processor 84may compare to the total dosage proposed for delivery during analysiswindow 108 to a reference dosage, e.g., to determine whether to applythe proposed therapy dosing program based on this “worst” case.

FIG. 6D represents the “worst” case for the timing of first and secondboluses 107 during the proposed therapy program in term of overdose,e.g., when the proposed therapy program authorizes two boluses during a24-hour period. In FIG. 6D, the duration of analysis window 108 is justlonger than that shown in FIG. 6C. Analysis window 108 is shownoverlapping this “worst” case such that the total dosage during theanalysis window corresponds to the maximum dosage that patient 12 may bedelivered by IMD 12. Again, processor 84 may compare to the total dosageproposed for delivery during analysis window 108 to a reference dosage,e.g., to determine whether to apply the proposed therapy dosing programbased on this “worst” case.

In FIG. 6E, box 107 overlaps the portion the proposed therapy programcorresponding to the “worst” case for the timing of the bolus (in thecase where a single bolus is authorized during a 24-hour period) duringthe proposed therapy program in term of overdose. Unlike that above, box107 represents a bolus that has rate less than the maximum rate definedby the therapy schedule. As such, analysis window 108 does not overlap aportion of bolus 107 but instead overlaps a portion of the step definingthe maximum rate. Again, processor 84 may compare to the total dosageproposed for delivery during analysis window 108 to a reference dosage,e.g., to determine whether to apply the proposed therapy dosing programbased on this “worst” case.

FIG. 6F illustrates an example similar to that of FIG. 6E. However, theduration of analysis window 108 is longer and the “worst” case is shownin terms of underdose rather than overdose. In the example of FIG. 6F,the bolus is delivered at a time that overrides a period of the therapyschedule defining the maximum rate. In such a case, such an override dueto the bolus effectively lowers rate compared to that defined by atherapy schedule, and defines the “worst” case for the proposed therapyprogram in terms of underdose. As described above, processor 84 maycompare to the total dosage proposed for delivery during analysis window108 to a reference dosage range (and, in particular, the minimumreferences dosage value defined by the reference range), e.g., todetermine whether to apply the proposed therapy dosing program based onthis “worst” case.

In some examples, processor 84 may utilize one or more of the techniquesdescribed in this disclosure to evaluate multiple therapy dosingprograms, either individually or in combination with one another. Asdescribed above, in some examples, the same therapy dosing program maybe repeated to define therapy over a period of time that greater thanthe overall time period of the therapy dosing program. For example, adaily therapy dosing program may be repeated seven times to definetherapy delivered to a patient over a week's time. Additionally oralternatively, in some examples, two or more different therapy dosingmay be used in direct succession to define therapy delivered to patient16 via IMD 12. In each case, there may be a period of time including aportion at the end of a first therapy dosing program and a portion atthe beginning of the following therapy dosing program during which apotentially unacceptable dose may be programmed for delivery to patient16 via IMD 12.

In accordance with one or more examples of the disclosure, processor 84(and/or other processor) may evaluate two proposed dosing programs incombination with one another via an analysis window with one portionwithin one of the proposed therapy dosing programs and another portionwithin the other of the proposed therapy dosing programs. Similar tothat described above, processor 84 may determine the total dosageproposed for delivery during such an analysis window, and compare thetotal dosage to a reference dosage defined based on the duration ofanalysis window. In some examples, processor 84 may determine whether toapply the combination of the two proposed therapy dosing programs basedon the comparison.

FIG. 7 is a conceptual diagram illustrating example representation of anexample therapy defined by two example therapy dosing programs. Inparticular, the example therapy of FIG. 7 is defined first by a firstproposed therapy dosing program 110 followed by second proposed therapydosing program 112. As shown, the overall time period of each proposeddosing program represented in FIG. 7 is approximately twenty-four hours.When used in combination with each other, first and second proposedtherapy dosing programs 110, 112 may define therapy for delivery topatient 16 via IMD 12 over a period of approximately forty-eight hours.

In FIG. 7, line 116 represents the rate and duration defined by firstproposed therapy dosing program 110, and line 118 represents the rateand duration defined by second proposed therapy dosing program 112. Asdescribed above, the rate and duration information for each proposeddosing program may be defined by therapy schedules and/or the potentialfor bolus delivery during the time periods of the respective dosingprograms 110, 112. Although first and second therapy dosing programs110, 112 are shown as being different with respect to rate and duration,in other examples, first and second therapy dosing programs 110, 112 maybe substantially the same therapy dosing program.

A clinician may propose the combination of first therapy dosing program110 followed by second therapy dosing program 112, e.g., usingprogrammer 20 during a programming session, to define therapy over aforty-eight hour time period. Upon receipt of the proposed combinationof first therapy dosing program 110 and second therapy dosing program112, processor 84 may evaluate the proposed combination by determiningthe total dosage proposed for delivery within analysis window 114 duringone or more periods overlapping the first therapy dosing program 110and/or second therapy dosing program 112. In the example of FIG. 7,analysis window 114 has a duration of approximately 8 hours, althoughother durations are contemplated for analysis window 114.

As shown in FIG. 7, analysis window 114 may overlap a portion of firsttherapy dosing program 110 and a portion of second therapy dosingprogram 112, in which case the total dosage proposed for delivery duringanalysis window 114 determined by processor 84 depends on both firsttherapy dosing program 110 and second therapy dosing program 112.Additionally or alternatively, processor 84 may determine the totaldosage for one or more analysis windows entirely within first therapydosing program 110 and/or second therapy dosing program. Similar to thatdescribed above, analysis window 114 may be moved to a plurality ofdifferent locations (or “swept”) over substantially all or portions ofthe overall time period defined by the combination of first therapydosing program 110 and second therapy dosing program 112 to detect anyperiods of time during which the total dosage delivered to patient 16would be outside the reference dosage range defined for the duration ofanalysis window 114.

As analysis window 114 may overlap portions of first therapy dosingprogram 110 and second therapy dosing program 112, by comparing thetotal dosage within analysis window 114 to a reference dosage range,processor 84 may identify time periods during which a potentiallyunacceptable dose may be programmed for delivery to patient resultingfrom the proposed combination of first therapy dosing program 112 andsecond therapy dosing program 114. This may be the case even if thereare no time periods during first therapy dosing program 110 and secondtherapy dosing program 112, when evaluated individually, for which thetotal dosage within analysis window 114 is outside that of the referencedosage range.

In some examples, if processor 84 determines that the total dosageproposed for delivery when analysis window 114 overlaps a portion ofboth first therapy dosing program 110 and second therapy dosing program114 is outside the reference dosage range, processor 84 may not directlyapply the proposed combination to prevent IMD 12 from delivery therapyto patient 16 according to the proposed combination. Conversely, ifprocessor 84 determines that there are no time periods for which thetotal dosage proposed for delivery when analysis window 114 overlaps aportion of one or both of first therapy dosing program 110 and secondtherapy dosing program 114 is outside the reference dosage range,processor 84 may apply first therapy dosing program 110 and secondtherapy dosing program 112, in the proposed combination, such that IMD12 may deliver therapy to patient 16 according to the combination.Additionally or alternatively, processor 84 may present an indication ofthe comparison to a user via user interface 82, and user may indicate toprogrammer 84 via user interface 82 if the proposed therapy programsshould be applied in combination to define therapy delivered to patient12.

FIG. 8 is a conceptual diagram illustrating an example screen 120 ofexample user interface 82 (FIG. 3) for displaying an indicator of one ormore proposed therapy dosing program. Processor 84 may generate anddisplay screen 120 via user interface 82 to allow a user to visualizeone or more aspects of a proposed therapy dosing program. For example,as shown, screen 120 may display a plot of rate versus time over aperiod of twenty-four hours, as defined by a proposed therapy dosingprogram. For ease of illustration, in FIG. 8, screen 120 is showndisplaying substantially the same proposed therapy dosing program shownin FIG. 5. However, any other proposed therapy dosing program orproposed combination of therapy dosing programs may be displayed in asubstantially similar manner.

In some examples, screen 120 may be displayed by programmer 20 afterprocessor 84 has determined that a proposed therapy dosing programdefines a total dosage within one or more analysis windows outside areference dosage range based on a comparison of the total dosageproposed for delivery during one or more analysis windows, as describedabove. In addition to displaying one or more therapy parameters (e.g.,proposed rate and time) for a proposed therapy dosing program, screen120 may also include an indicator indicating the one or more timeperiods for which the total dosage resulted in the rejection of theproposed therapy dosing program. For example, screen 200 includeshighlighted indicator 122 which overlay a portion of the plot defined bythe proposed therapy dosing program. As positioned, indicator 122 maycorrespond to an analysis window for which processor 84 has determinedthat the total dosage during the window is outside the reference dosagerange. In this manner, indicator 122 may indicate to a clinician orother user the particular period of time during the proposed therapydosing schedule that the total dosage may be unacceptable, as defined bythe reference dosage range. Although screen 120 display only a singlehighlighted indicator 122 in FIG. 8, screen 120 may simultaneously orsequentially display a plurality of highlighted indicators at differentperiod of time within the proposed therapy dosing program to indicate aplurality of analysis windows for which processor 84 has determined thatthe total dosage during the window is outside the reference dosagerange.

Based in part on screen 120, a clinician or other user may determinewhat action to take after processor 84 has alerted the user to theresults of the comparison. As noted above, in some examples, a clinicianmay input one or more modifications to the proposed therapy dosingprogram, particularly in relation to the therapy proposed for deliveryduring an analysis window for which the total dosage was outside thereference dosage range. Screen 120 may assist a clinician by identifyingsuch time periods via highlighted indicator 122.

In some examples, a clinician may modify the rate or other therapyparameter (e.g., bolus authorization information) defined by proposedtherapy dosing program during the period of time overlaid by highlightedindicator 122 using user interface 82 of programmer 20. Once modified,processor 84 may re-evaluate the proposed therapy dosing program, in themodified form, using one or more of the techniques described in thisdisclosure. In some examples, highlighted indicator 122 may remain onscreen until the modification made to the proposed therapy dosingprogram results in a total dosage over the indicated time period that iswithin the reference dosage range.

In some examples, where processor 84 identifies multiple analysiswindows defining a total dosage outside the reference dosage, screen 120may sequentially move a clinician through such windows starting with theanalysis window with the greatest difference between the total dosageand reference dosage and ending with the analysis window with thesmallest difference between the total dosage and reference dosage. Insome examples, a user may navigate through the multiple analysis windowsusing one or more buttons or other user feature of user interface 82. Insome examples, screen 120 may present period of overdose and underdoseto a user separately from one another.

In some examples, screen may also indicate the total dosage to a userwithin an analysis window and/or percent difference between the proposedtotal dosage and the average or reference dosage (e.g., via text orother graphical indicator). In some examples, screen 120 may indicate arecommended resolution or adjustment to the proposed therapy program toa user (e.g., including a breakout of contributors between repeatingprofiles, patient and/or clinician bolus).

In some examples, screen 120 and user interface 82 may allow a user todismiss a specific alert for a specific analysis window or all alerts ofa particular class, e.g., for a programming session or for a certainpatient, drug, programmer, and the like. In some examples, a user may beable to exclude certain types of infusion (e.g., clinician or patientdirected events) on a specific or global basis. In some examples, a usermay be able to define or alter a reference dosage range or alter theduration of an analysis window, e.g., to increase or decrease thesensitivity of the evaluation. All or some of the functionality andinformation described above may be presented immediately on screen 120or hidden under an access method, such as, a button or context menu.

The techniques described in this disclosure may be implemented, at leastin part, in hardware, software, firmware or any combination thereof. Forexample, various aspects of the techniques may be implemented within oneor more microprocessors, DSPs, ASICs, FPGAs, or any other equivalentintegrated or discrete logic circuitry, as well as any combinations ofsuch components, embodied in programmers, such as physician or patientprogrammers, stimulators, or other devices. The term “processor” or“processing circuitry” may generally refer to any of the foregoing logiccircuitry, alone or in combination with other logic circuitry, or anyother equivalent circuitry.

Such hardware, software, and firmware may be implemented within the samedevice or within separate devices to support the various operations andfunctions described in this disclosure. In addition, any of thedescribed units, modules or components may be implemented together orseparately as discrete but interoperable logic devices. Depiction ofdifferent features as modules or units is intended to highlightdifferent functional aspects and does not necessarily imply that suchmodules or units must be realized by separate hardware or softwarecomponents. Rather, functionality associated with one or more modules orunits may be performed by separate hardware or software components, orintegrated within common or separate hardware or software components.

When implemented in software, the functionality ascribed to the systemsand devices described in this disclosure may be embodied as instructionson a computer-readable medium such as RAM, ROM, NVRAM, EEPROM, FLASHmemory, magnetic media, optical media, or the like. The instructions maybe executed to support one or more aspects of the functionalitydescribed in this disclosure.

If implemented in software, the techniques described in this disclosuremay be stored on or transmitted over as one or more instructions or codeon a computer-readable medium. Computer-readable media may includenon-transitory computer storage media or communication media includingany medium that facilitates transfer of a computer program from oneplace to another. Data storage media may be any available media that canbe accessed by one or more computers or one or more processors toretrieve instructions, code and/or data structures for implementation ofthe techniques described in this disclosure. By way of example, and notlimitation, such data storage media can comprise RAM, ROM, EEPROM,CD-ROM or other optical disk storage, magnetic disk storage, or othermagnetic storage devices, flash memory, or any other medium that can beused to store desired program code in the form of instructions or datastructures and that can be accessed by a computer. Also, any connectionis properly termed a computer-readable medium. For example, if thesoftware is transmitted from a website, server, or other remote sourceusing a coaxial cable, fiber optic cable, twisted pair, digitalsubscriber line (DSL), or wireless technologies such as infrared, radio,and microwave, then the coaxial cable, fiber optic cable, twisted pair,DSL, or wireless technologies such as infrared, radio, and microwave areincluded in the definition of medium. Disk and disc, as used herein,includes compact disc (CD), laser disc, optical disc, digital versatiledisc (DVD), floppy disk and blu-ray disc where disks usually reproducedata magnetically, while discs reproduce data optically with lasers.Combinations of the above should also be included within the scope ofcomputer-readable media.

The code may be executed by one or more processors, such as one or moredigital signal processors (DSPs), general purpose microprocessors,application specific integrated circuits (ASICs), field programmablelogic arrays (FPGAs), or other equivalent integrated or discrete logiccircuitry. Accordingly, the term “processor,” as used herein may referto any of the foregoing structure or any other structure suitable forimplementation of the techniques described herein. Also, the techniquescould be fully implemented in one or more circuits or logic elements.

Various examples have been described. These and other examples arewithin the scope of the following claims.

1. (canceled) 2: A system comprising processing circuitry configured to:receive, via a network, a therapy dosing program from a medical fluiddelivery device, the medical fluid delivery device being configured todeliver a therapeutic fluid agent to a patient according to the therapydosing program; compare a total dosage defined by the therapy dosingprogram to a reference dosage; and transmitting, via the network, anindication of the comparison to an external device. 3: The system ofclaim 2, wherein the processing circuitry is configured to compare thetotal dosage to the reference dosage by at least determining that thetotal dosage is outside a range defined by the reference dosage. 4: Thesystem of claim 2, wherein the reference dosage comprises a non-patientspecific reference dosage. 5: The system of claim 2, further comprisingthe external device, wherein the external device is configured to, basedon the transmitted indication, generate an alert via a user interface ofthe external device indicating the comparison between the total dosageand the reference dosage. 6: The system of claim 2, wherein theprocessing circuitry is configured to: receive, via the network,instructions to modify the therapy dosing program from the externaldevice after transmitting the indication; and transmit, via the network,the instructions to the medical fluid delivery device based on thereceipt of the instructions from the external device. 7: The system ofclaim 6, further comprising the medical fluid delivery device, whereinthe medical fluid delivery device is configured to, based on receipt ofthe transmitted instructions, control delivery of the therapeutic fluidagent to the patient according to the modified therapy dosing program.8: The system of claim 2, wherein the processing circuitry is configuredto transmit the indication of the comparison to the external device byat least transmitting, via the network, a recommended adjustment to thetherapy dosing program to the external device. 9: The system of claim 2,wherein the therapy dosing program comprises a proposed therapy dosingprogram, wherein the processing circuitry is configured to: receive, viathe network, instructions confirming the proposed therapy dosing programfrom the external device after transmitting the indication; andtransmit, via the network, the instructions to the medical fluiddelivery device based on the receipt of the instructions from theexternal device. 10: The system of claim 2, wherein the networkcomprises a wide area network. 11: The system of claim 2, furthercomprising: the medical fluid delivery device; and the external device.12: A method comprising: receiving, via a network, a therapy dosingprogram from a medical fluid delivery device, the medical fluid deliverydevice being configured to deliver a therapeutic fluid agent to apatient according to the therapy dosing program; comparing a totaldosage defined by the therapy dosing program to a reference dosage; andtransmitting, via the network, an indication of the comparison to anexternal device, wherein the receiving, comparing, and transmitting areperformed via processing circuitry. 13: The method of claim 12, whereincomparing the total dosage to the reference dosage comprises determiningthat the total dosage is outside a range defined by the referencedosage. 14: The method of claim 12, wherein the reference dosagecomprises a non-patient specific reference dosage. 15: The method ofclaim 12, further comprising generating, based on the transmittedindication, an alert via a user interface of the external deviceindicating the comparison between the total dosage and the referencedosage. 16: The method of claim 12, further comprising: receiving, viathe network, instructions to modify the therapy dosing program from theexternal device after transmitting the indication; and transmitting, viathe network, the instructions to the medical fluid delivery device basedon the receipt of the instructions from the external device. 17: Themethod of claim 16, further comprising controlling delivery of thetherapeutic fluid agent to the patient according to the modified therapydosing program. 18: The method of claim 12, wherein transmitting theindication of the comparison to the external device comprisestransmitting, via the network, a recommended adjustment to the therapydosing program to the external device. 19: The method of claim 12,wherein the therapy dosing program comprises a proposed therapy dosingprogram, the method further comprising: receiving, via the network,instructions confirming the proposed therapy dosing program from theexternal device after transmitting the indication; and transmitting, viathe network, the instructions to the medical fluid delivery device basedon receipt of the instructions from the external device. 20: The methodof claim 12, wherein the network comprises a wide area network. 21: Anon-transitory computer-readable storage medium comprising instructionsthat cause one or more processors to: receive, via a network, a therapydosing program from a medical fluid delivery device, the medical fluiddelivery device being configured to deliver a therapeutic fluid agent toa patient according to the therapy dosing program; compare a totaldosage defined by the therapy dosing program to a reference dosage; andtransmitting, via the network, an indication of the comparison to anexternal device.